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Pain-Reduction Techniques for Infant Immunization Pain
Phase 3
Waitlist Available
Led By Anna Taddio, PhD
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 2,4,6,12 month vaccinations (visit 1-4)
Awards & highlights
Study Summary
This trial is testing different ways to ease the pain of routine immunization shots for infants.
Who is the study for?
This trial is for healthy infants getting their routine vaccination shots. Infants born prematurely, those who've had hospital stays or surgery (except right after birth), or have allergies to certain anesthetics or vaccines can't participate. Also, if the mother intends to breastfeed, use sugar water, or topical anesthetics during the shot, the infant isn't eligible.Check my eligibility
What is being tested?
The study tests how effective different pain-relief methods are when babies get their shots. It compares using a sweet solution (sucrose) and numbing cream (lidocaine) against placebo versions of these treatments along with educational videos for parents that either contain active advice or sham information.See study design
What are the potential side effects?
Possible side effects may include discomfort at the site where lidocaine is applied and sensitivity reactions in some infants. The sucrose solution is generally safe but could cause mild digestive upset.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 2,4,6,12 month vaccinations (visit 1-4)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2,4,6,12 month vaccinations (visit 1-4)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hypersensitivity to pain
Secondary outcome measures
Effectiveness of interventions
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: Group 3Active Control3 Interventions
Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar
Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.
Group II: Group 2Active Control3 Interventions
Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain
Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.
Group III: Group 4Active Control3 Interventions
Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar water and a topical anesthetic
Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.
Group IV: Group 1Placebo Group3 Interventions
Visit 1-4 (2,4,6,12 month vaccinations): Patients will receive standard care
Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.
Find a Location
Who is running the clinical trial?
The Hospital for Sick ChildrenLead Sponsor
686 Previous Clinical Trials
6,944,441 Total Patients Enrolled
22 Trials studying Pain
6,549 Patients Enrolled for Pain
Anna Taddio, PhDPrincipal InvestigatorThe Hospital for Sick Children
16 Previous Clinical Trials
18,328 Total Patients Enrolled
5 Trials studying Pain
1,080 Patients Enrolled for Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been hospitalized or had surgery before, not including after childbirth.My infant is healthy and getting vaccinated.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 3
- Group 3: Group 2
- Group 4: Group 4
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What type of patients does Group 3's medication usually help?
"The third group's medical interventions are effective for treating patients with cervical syndrome, who have received minor burns, and those who have undergone transplantation."
Answered by AI
How many test subjects are receiving treatment as part of this research?
"This particular study is not recruiting patients at this time. The trial was first posted on December 1st, 2011 and was most recently updated on November 9th, 2015. If you are looking for other studies, there are 623 clinical trials actively recruiting patients with pain and 140 studies for Group 3 admitting patients."
Answered by AI
Does this research allow participants who are octogenarians?
"This trial is only for infants aged 2 to 15 months old. Out of the 711 total clinical trials, this is one of 171 trials for patients under 18 and 540 trials for patients over 65."
Answered by AI
What other research groups have studied Group 3 in the past?
"Right now, there are 140 ongoing studies being conducted for Group 3 with 34 of those trials in Phase 3. Some of the studies for Group 3 are running out of in Calgary, Alberta, but there are 1124 locations operating studies for Group 3 in total."
Answered by AI
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